Total Intravenous vs Spinal Anesthesia for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare same-day discharge rates and recovery outcomes across an adult patient population undergoing elective Total Knee Arthroplasty (TKA), and randomized to receive either spinal block anesthesia or Total IntraVenous Anesthesia (TIVA).
Primary Aim: assess same-day discharge rates between study arms (TIVA vs spinal).
Secondary Aim: Postoperative comparison of recovery during PostOperative Anesthesia Care Unit (PACU) admission, diagnostic assessment scores; outcomes related to cognition, hemodynamic stability, pain, nausea and vomiting; analysis of IntraOperative electroencephalogram (EEG) monitoring metrics, e.g., total suppression time, average Bi-spectral Index monitor (BIS) value, Spectral Edge Frequency (SEF); ability for Physical Therapy (PT) evaluation prior to discharge; longterm-followup (LTFU), hospital readmission, return to surgery, etc.; adverse event (AE) monitoring.
Who Is on the Research Team?
Zheng Xie, MD, PhD
Principal Investigator
University of Chicago, Department of Anesthesia and Critical Care
Are You a Good Fit for This Trial?
This trial is for adults scheduled to have a planned (elective) total knee replacement on one knee. Participants must be able to safely receive either spinal anesthesia or intravenous anesthesia, as determined by their doctors.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Spinal-Block
- Total IntraVenous Anesthesia (TIVA)
Trial Overview
The study compares two types of anesthesia—spinal block versus total intravenous anesthesia (TIVA)—in patients having knee replacement surgery. Patients are randomly assigned to one group and monitored during and after surgery, including with brain activity tests (EEG).
How Is the Trial Designed?
2
Treatment groups
Active Control
Arm A (TIVA): Induction and maintenance intravenously (propofol, dexmedetomidine, fentanyl, hydromorphone); no volatile agents. Anesthetic depth titration based on clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring.
Arm B (Spinal): Single-shot intrathecal mepivacaine-2%, 3.0 milliliters (mL) per institutional standard. Light propofol sedation is permitted at clinician discretion, titrated to comfort and clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
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